Registration Dossier
Registration Dossier
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EC number: 618-990-3 | CAS number: 939961-06-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-amino-N-(4-carbamoylphenyl)-4-methoxybenzamide hydrochloride
- EC Number:
- 618-990-3
- Cas Number:
- 939961-06-5
- Molecular formula:
- C15H15N3O3xClH
- IUPAC Name:
- 3-amino-N-(4-carbamoylphenyl)-4-methoxybenzamide hydrochloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG, kastengrund, SPF-breeding
- Age at study initiation: males: about 7 weeks; females: about 8 weeks
- Weight at study initiation: males: 177 - 193 grams; females: 175 - 186 grams
- Fasting period before study: about 16 hours
- Housing: in completely air conditioned rooms in macrolon cages in groups of 5 animals
- Diet: Ratten diät Altromin 1324, Altromin GmbH, Lage/Lippe, ad libitum
- Water: tap water from plastic bottles, ad libitum
- Acclimation period: not required since breeding under the same conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 55+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: potatoe starch (2% in deionized water)
- Details on oral exposure:
- see below
- Doses:
- Dosis Concentration application-volume number of animals
(mg/kg bw) (% (w/v)) (ml/kg bw) males females
2000 20 10 5 5 - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice a day and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- 1 male and 1 female animal for each dose.
Doses: 500, 1000, 2000 mg/kg bw.
No mortality, only unspecific symptoms and irregular aspirate
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- other: Squatting posture, flanks pinched in, increased respiration. Two dayas after the application these symptoms were completely reversible.
- Gross pathology:
- After the observation period the animals did not show any macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Due to the LD50>2000 mg/kg bw the substance is not subject for classification for acute oral toxicity.
- Executive summary:
The substance was tested for acute oral toxicity to the Wistar-rat according to OECD guideline 401. A pre-test was performed with one male and one female rat for each dose of 500, 1000 and 2000 mg/kg bw. There was no mortality in this pre-test. For the main test 5 male and 5 female animals were administered a single dose of 2000 mg/kg bw by gavage. No mortality occured up to the observation period of 14 days but unspecific symptoms such as squatting posture, pinched in flanks and increased respiration could be noticed. Two dayas after the application these symptoms were completely reversible.
There was no effect on the development of the body weight and after section of the killed animals no macroscopic findings were present.
The LD50 is therefore greater than 2000 mg/kg bw
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